Recruiting

ctDNA Biomarker

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT05081024

Conditions

Rectal Adenocarcinoma

Stage II Rectal Cancer AJCC v8

Stage IIA Rectal Cancer AJCC v8

Stage IIB Rectal Cancer AJCC v8

Stage IIC Rectal Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy

Biospecimen Collection

Electronic Health Record Review

Study Details

Brief summary:

This study measures the levels of circulating tumor DNA (ctDNA) in patients with stage II-III rectal cancer before, during, and after treatment to find out if the presence or absence of ctDNA in patient's blood using the Signatera test can be used to gauge how different treatments may affect rectal cancer. ctDNA is DNA from the rectal cancer that is circulating in the blood. The purpose of this study is to understand if the way rectal tumors respond to standard treatment can be associated with varying levels of ctDNA.

Conditions

Rectal Adenocarcinoma

Stage II Rectal Cancer AJCC v8

Stage IIA Rectal Cancer AJCC v8

Stage IIB Rectal Cancer AJCC v8

Stage IIC Rectal Cancer AJCC v8

Study ID

NCT05081024

Start date

Sep 3, 2021

Status verified date

Sep, 2025

Completion date

Sep 3, 2026

Anticipated

Primary completion date

Sep 3, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participant must provide written informed consent before any study-specific procedures or interventions are performed
  • Participants aged >= 18 years
  • Pathologically-confirmed stage II or III primary adenocarcinoma of the rectum:

  • T3N0M0 - T4bN2M0

Exclusion Criteria:

  • Has radiologic evidence of distant metastases at the time of screening/enrollment
  • Has received prior treatment for their rectal adenocarcinoma
  • Requires or has received blood transfusion within 1 month of study enrollment

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (biospecimen collection, medical record review)

Patients undergo collection of blood samples at baseline (before any neoadjuvant therapy), every 2 months while undergoing TNT, and then every 3 months for up to 3 years after completion of TNT. Patients' medical records are also reviewed. Patients may undergo collection of tissue sample if an archival tissue sample is not available.

Interventions

Biopsy

Undergo biopsy

Biospecimen Collection

Undergo collection of blood and/or tissue samples

Electronic Health Record Review

Medical records are reviewed

Primary outcome measure

  • Complete clinical response (cCR) [ Time Frame: From time of treatment start up to date of completing total neoadjuvant therapy (TNT), up to 3 months. ]

Central Contacts and Locations

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Adel Kardosh, M.D.,Ph.D.

503-494-5207kardosh@ohsu.edu

Principal Investigator:

Adel Kardosh, M.D.,Ph.D.

Fred Hutch

Recruiting

Seattle, Washington, United States, 98109

Contacts

Stacey Cohen, MD

206-606-6658shiovitz@uw.edu

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

Sep 25, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2025-09-25.